LXE408 Novartis for CL

LXE408 is a selective, pan-kinetoplastid proteasome inhibitor discovered at Novartis with financial support from Wellcome. It has potent anti-parasitic activity against all kinetoplastid parasites tested to date, which include Leishmania species that cause visceral (L. donovani, L. infantum) and cutaneous leishmaniasis (including L. major and L. braziliensis) as well as Trypanosoma species that cause Chagas disease (T. cruzi) and human African trypanosomiasis (T. brucei).

The efficacy, safety, and pharmacokinetics of LXE408 are being evaluated in patients with visceral leishmaniasis in two ongoing Phase II studies in India and Ethiopia.

In a Phase II, randomized, multicentre, observer-blinded study, DNDi and partners will evaluate the safety, efficacy, and pharmacokinetic profile of two oral LXE408 regimens compared with oral miltefosine as active control in patients with localized cutaneous leishmaniasis in the region of the Americas, and assess the suitability of LXE408 for use in monotherapy for the treatment of patients with cutaneous leishmaniasis.